EP0638281A1 - Appareil pour analyser des ondes pulsées - Google Patents

Appareil pour analyser des ondes pulsées Download PDF

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Publication number
EP0638281A1
EP0638281A1 EP94305727A EP94305727A EP0638281A1 EP 0638281 A1 EP0638281 A1 EP 0638281A1 EP 94305727 A EP94305727 A EP 94305727A EP 94305727 A EP94305727 A EP 94305727A EP 0638281 A1 EP0638281 A1 EP 0638281A1
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EP
European Patent Office
Prior art keywords
pulse wave
pressure
pulse
analysis device
waves
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EP94305727A
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German (de)
English (en)
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EP0638281B1 (fr
Inventor
Kazuhiko C/O Seiko Epson Corporation Amano
Hiromitsu Ishii
Kazuo Kodama
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Seiko Epson Corp
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Seiko Epson Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A61B5/02116—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave amplitude
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A61B5/02233—Occluders specially adapted therefor
    • A61B5/02241—Occluders specially adapted therefor of small dimensions, e.g. adapted to fingers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • A61B5/02422—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation within occluders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A61B5/6826—Finger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6838—Clamps or clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A61B5/7257—Details of waveform analysis characterised by using transforms using Fourier transforms

Definitions

  • the present invention relates to pulse wave analysis devices that analyze the condition of the body based on pulse waves obtained from the body.
  • the inventors of the present invention have studied the relationship between pulse waves and physical health from the aforementioned standpoint with the intention of developing an apparatus capable of analyzing the state of one's health based on pulse waves. Their studies have determined that the waveform of a pulse wave changes as a function of the pressure applied at the pressure measurement site. It is well known that illness is closely related to the dynamic characteristics of a person's blood vessels. If it is possible to determine objectively the behavior of pulse waves with respect to applied pressure, the diagnosis of a patient's illness will be greatly improved both in terms of speed and objectivity. The present invention was developed against this background. Its objective is to provide a pulse wave analysis device capable of determining the behavior of pulse waves with respect to applied pressure in an objective manner.
  • Fingertip plethysmograms are blood stream pulse waves in the peripheral circulation system and can be measured non-invasively. These pulse waves are receiving increasing attention as a means of evaluating the state of peripheral circulation, the concentration of oxygen in the blood, and the extent of fatigue or stress felt by the body.
  • observations were made by applying varying pressure to the peripheral tissue at the tip of a finger and by determining the resulting change in the frequency spectrum of the fingertip plethysmograms.
  • the ends of the artery system which are small arteries, divide into mesh-like capillaries which then join together to form small veins. These capillary vessels cover an extremely large total area.
  • the subject's finger was pressed against the head of an optical fingertip plethysmogram sensor in order to detect fingertip plethysmograms.
  • the fast Fourier transform (FFT) was used to determine the spectrum for these pulse waves.
  • the first subject was a 25-year-old male with a blood pressure of 54 mmHg over 104 mmHg.
  • the second subject was a 32-year-old male with a blood pressure of 58 mmHg over 96 mmHg.
  • Measurements were taken from each subject after the subject rested for 20 minutes, in the sitting position, after fasting.
  • the pulse wave data were analog/digital converted every 20 milliseconds and measurements were taken for a total of 80 seconds. During the 80 second measurement time each subject was required to control his breathing at a rate of 12 inhalations per minute.
  • Figure 2 shows an amplified waveform of subject A's pulse wave signals at an applied pressure of 67 g/cm2.
  • the horizontal axis shows time (in seconds) and the vertical axis shows voltage (mV).
  • This graph indicates envelope components that change relatively gradually in addition to pulse wave signals.
  • (4)-2 FFT analysis of pulse waveforms in Figure 3 shows the results of FFT analysis of the pulse wave data of Figure 2 where the horizontal axis indicates frequencies (Hz) and the vertical axis, the power (amplitudes) (mV).
  • Figure 4 shows the relative levels of the second through eighth harmonic waves, treating the fundamental wave (1.2 Hz) as level 1, of the results of the FFT analysis of the data on subject A and of the results of the FFT analysis of similarly calculated various pressures that were applied.
  • the horizontal axis indicates the orders of spectra and the vertical axis shows relative values.
  • This graph shows a variability (scattering) due to pressure differences in a range from the second to the eighth harmonic waves. This variability appears to be a characteristic of subject A.
  • Figure 5 shows the amplitudes (solid line A-S1) of the fundamental wave for the pulse wave spectrum at various pressures for subject A and the amplitudes (solid line A-S2) of the second harmonic wave.
  • the horizontal axis indicates the applied pressure (g/cm2), and the vertical axis shows amplitudes (mV).
  • Line L indicates the 5 mV amplitude level.
  • Figure 6 shows the amplitudes (broken line B- S1) of the fundamental wave for the pulse wave spectrum at various pressures for subject B and the amplitudes (broken line B-S2) of the second harmonic wave.
  • the graph in Figure 7 is the graphs of Figures 5 and 6 plotted together.
  • subject B Compared with subject A, subject B produces larger signals at the higher pressure range of 67 g/cm2 to 133 g/cm2. It is therefore inferred that subject B has a higher viscoelasticity in his peripheral circulation tissue than subject A does.
  • This present invention was developed based on the information obtained as described above.
  • the present invention provides a pulse wave analysis device which provides an information indicating the status of a living body.
  • the pulse wave analysis device detects pulse waves from the living body and the pressure applied at the site on the body at which pulse waves are detected.
  • the pulse wave analysis device identifies a variation pattern of the pulse waves thus detected relative to a change in the pressure that is applied at the detection site.
  • the variation pattern thus identified provides a useful information with respect to the illness or symptoms of the living body.
  • a pressurization means may be employed in the pulse wave analysis device to applies the desired pressures to the pulse wave detection site on the body.
  • a pressure control means may be preferably employed in the pulse wave analysis device for stepwise varying the pressure applied by the pressurization means at the detection site.
  • the pulse waves corresponding to the pressures applied at the detection site are detected and the above-described variation pattern is determined based on the pulse waveforms thus detected and the pressures thus applied.
  • a cuff band for wrapping a part of the body and an air pump that supplies air to the cuff band are employed as the pressurization means.
  • the pressure control means regulates the amount of air supplied from the air pump to the cuff band so that the pressure applied at the detection site equals a target value.
  • a display means may be preferably employed in the device for displaying a graph of the target pressure value to be applied at the pulse wave detection site and the detected pressure.
  • the device enables the pulse wave detection to detect pulse waves when the pressure detected by the pressure detection means is within the range corresponding to a target pressure value.
  • the target pressure value may be sequentially and stepwise varied and is issued as an instruction which instructs each target value.
  • the frequency analysis may be performed in order to determine the variation pattern.
  • the variation pattern of the pulse waveforms is obtained by determining the spectral change patterns that correspond to a change in pressure as obtained by the frequency analysis.
  • a pattern memory may be preferably employed in the pulse wave analysis device for storing the pulse wave spectra, corresponding to the pressures applied at the detection site, as patterns for each predetermined body condition.
  • the pulse wave analysis device outputs the pattern that is closest, among the patterns stored in the pattern memory, to the pulse wave spectrum corresponding to the pressures determined by the frequency analysis.
  • the pulse wave analysis device may be designed so as to output pressure values such that the amplitudes of the pulse wave spectra corresponding to the various pressures determined by the frequency analysis are less than a specified value.
  • waveform shape analysis may be preferably performed to detects the level ratios of the peaks that appear in the detected pulse waves, and the rise time of the pulse waves.
  • the pattern is determined as a pattern of change in the level ratios and rise times corresponding to pressure changes.
  • the pattern memory stores, as patterns, both the level ratios corresponding to pressure changes and changes in rise time, for each predetermined body condition.
  • the pulse wave analysis device can output the pattern that is closest, among the patterns stored in the pattern memory means, to the pattern of change in level ratio and rise time as detected by the waveform shape analysis.
  • the waveform shape analysis may be performed to detects the level ratios of the peaks that appear in the detected pulse waves and the rise time of the pulse waves.
  • the device may determine the level ratios corresponding to pressure changes and a pattern of change in rise time.
  • the pattern memory may be employed to store, as patterns, both the level ratios corresponding to pressure changes and changes in rise time, for each predetermined body condition. This device can select and output the pattern that is closest, among the patterns stored in the pattern memory means, to the pattern of change in level ratio and rise time as detected by the waveform shape analysis.
  • the waveform shape analysis may be performed to detect both the time ratio of the pulse wave stroke period, as detected, to the length of time in which the waveform value of the pulse waves becomes greater than a specified value, and the rise time of the pulse waves.
  • This device can determine the time ratio corresponding to a pressure change and the pattern of change in rise time.
  • the pattern memory may store, as patterns, both the time ratios corresponding to pressure changes and changes in rise time, for each predetermined body condition. This device can select and output the pattern that is closest, among the patterns stored in the pattern memory, to the pattern of change in time ratio and rise time as detected by the waveform shape analysis.
  • the magnitude of the pressure applied to the body is varied stepwise, and the magnitude of the pressure is detected.
  • the pulse waves corresponding to the various pressures are detected from the body.
  • the pulse wave analysis device determines the pressure at which pulse waves satisfy specified conditions. More specifically, the pulse wave analysis device determines the pressure that maximized the ratio of the size of the peak of the overlapping waves to the size of the drive waves, and performs a diagnosis based on the rise time of the pulse waves at that pressure.
  • the device may determine the pressure that maximizes the ratio of the stroke period of the detected pulse wave to the time when the waveform value of that pulse wave becomes greater than or equal to a specified value, and may perform a diagnosis based on the rise time of the pulse waves at that pressure.
  • the power may be supplied through the use of the switching means only from the time the beginning of an analysis is indicated by the user to the time the end of the analysis is indicated.
  • the power may be supplied for a specified period of time through the use of the switching means, and the power supply operation is repeated at specified time intervals.
  • the power may be supplied for a specified period of time through the use of the switching means from the time the beginning of an analysis is indicated by the user to the time the end of the analysis is indicated, and the power supply operation is repeated at specified time intervals.
  • the switching means can reduce power consumption by the portable equipment.
  • Figure 1 shows the configuration of the pulse wave analysis device according to the first preferred embodiment of the present invention.
  • Figure 2 is a graph of pulse waveforms at a specified pressure values for the above embodiment.
  • Figure 3 is a graph of FFT analyses of the pulse waveforms for the above embodiment.
  • Figure 4 is a graph of relative levels of pulse wave spectra for the above embodiment.
  • Figure 5 is a graph which shows the relationship between applied pressure and the spectra for the above embodiment.
  • Figure 6 is a graph which shows the relationship between applied pressure and the spectra for the above embodiment.
  • Figure 7 is a graph which shows the relationship between applied pressure and the spectra for the above embodiment.
  • Figure 8 shows the configuration of a pulse wave analysis device built into a wrist-watch for the second preferred embodiment of the present invention.
  • FIG. 9 shows the internal configuration of the pulse wave analysis device for the same embodiment.
  • FIGS 10A and 10B show the drive timing for the pressure detection sensor for the same embodiment.
  • Figures 11A and 11B show an example of a guide message display during the operation of the pulse wave analysis device for the same embodiment.
  • Figure 12 is a graph which shows pulse waveforms and respiration waveforms, at different pressure values, for another another analysis example of the first preferred embodiment.
  • Figure 13 is a graph which shows the FFT analysis of pulse waveforms for the same analysis example.
  • Figure 14 is a graph which shows the relationship between applied pressure and spectra for the same analysis example.
  • Figure 15 is a graph which shows the relationship between, applied pressure and spectra for the same analysis example.
  • Figure 16 is a graph which shows the relationship between, applied pressure and spectra for the same analysis example.
  • Figure 17 is a graph of an enlargement of pulse waveforms relative to a specified pressure value for the same analysis example.
  • Figure 18 shows a locus between the ratio Vd/Vp as a function of change in pressure and the rise time Tr for the same analysis example.
  • Figure 19 shows the relationship between pressure and the ratio Vd/Vp for the same analysis example.
  • Figure 20 shows the relationship between age and rise time Tr when pressure is applied in each subject so that the ratio Vd/Vp reaches its maximum for the same analysis example.
  • Figure 21 shows the relationship between age and rise time Tr when pressure is applied in each subject so that the ratio Th/T reaches its maximum for the same analysis example.
  • Figure 22 shows the relationship between age and an arterial hardening index for the same analysis example.
  • Pulse waves are information that can be measured, either invasively or non-invasively, on the body.
  • Non-invasive methods for the determination of pulse waves include the determination of change in the lateral pressure in the blood vessel as a function of the output of blood from the heart and the determination of change in blood volume in a blood vessel.
  • Specific means of detection that are employed include light (visible and near-infrared), sound (audible and ultrasonic), and electromagnetic waves.
  • the embodiments refer to a pulse wave analysis device that uses near infrared radiation as a means of detection.
  • Figure 1 shows the configuration of the pulse wave analysis device according to the first preferred embodiment of the present invention.
  • 1 designates a cuff band, which is wrapped around the tip of the subject's either right or left second finger.
  • 3 designates an air pump.
  • 4 designates a pressure sensor.
  • 2 designates an air tube, which is provided as an air conduit between the cuff band 1, the air pump 3, and the pressure sensor 4.
  • the air pump 3 supplies the air to the cuff band 1 through the air tube 2.
  • the air increases the thickness of the cuff band 1 and causes it to squeeze finger tip F.
  • the pressure sensor 4 detects the air pressure supplied to the cuff band 1 through the air tube 2 and transmits the results to the CPU 5.
  • An optical pulse wave sensor 6 is provided inside the cuff band 1 in order to sense the fingertip plethysmograms of subjects.
  • the optical fingertip plethysmogram sensor 6 is composed of an infrared (940 nm wavelength) light-emitting diode 6a and an optical sensor 6b.
  • the light emitted by the infrared light-emitting diode 6b is reflected through the blood vessels at finger tip F and is picked up by the optical sensor 6b, where it undergoes a photoelectric conversion. Pulse wave signal M at finger tip F is detected by this process.
  • BPF band filter
  • ADC analog/digital converter
  • the ADC 9 converts the pulse wave signals (analog signals) supplied through the BPF 7 and the amplifier 8 into 8-bit digital signals that are quantized in 256 steps.
  • 5 denotes the CPU, 10 is a display, 11 is ROM, 12 is RAM.
  • the CPU 5 uses RAM 12 as a work area and performs the following processing based on the control program and control date stored in ROM 11.
  • the pulse wave analysis device operates and how to use it.
  • the cuff band 1 is wrapped around the tip of the right or left second finger of the subject, with the finger resting on the table.
  • the operator issues the start command to the CPU 5 by pressing the start key on the keyboard, which is not shown in the figure.
  • the CPU 5 Upon receiving this command, the CPU 5 regulates the amount of the air output from the air pump 3 so that the pressure reaches the first target value, 17 g/cm2. As the air pressure increases, the subject's finger tip, with the cuff band 1 wrapped around it, is gradually and increasingly pressed.
  • the CPU 5 While monitoring the pressure values supplied from the pressure sensor 4, the CPU 5 reads pulse wave digital signals from the ADC 9 when the applied pressure reaches the target value.
  • the pulse wave digital signals undergo the FFT processing in the CPU 5.
  • the calculated pulse wave spectral data are written to either RAM 12 or a storage means, such as an external storage device, which is not shown in the figure.
  • the CPU 5 regulates the amount of the air output from the air pump 3 so that the pressure reaches the second target value, 33 g/cm2. And, similarly, while monitoring the pressure values supplied from the pressure sensor 4, the CPU 5 reads pulse wave digital signals from the ADC 9 when the applied pressure reaches the target value, performs a spectral analysis, and stores the results. This processing is performed on each of the target pressure values mentioned above. For every applied pressure a spectral analysis of the corresponding pulse wave signals is performed and the results are saved automatically.
  • the CPU 5 calculates the final analytical results on a subject's circulation system as indicated below.
  • the CPU compares the amplitude levels of the fundamental wave with the second harmonic wave for each applied pressure, and outputs a pattern of change in amplitude level with respect to an increase in applied pressure.
  • patterns are divided into several groups, such as five groups A-E, according to their increase/decrease trends. For example, the patterns showing the greatest increasing trend are placed in the first group, and the patterns showing the greatest decreasing trend are placed in the fifth group. These groups are pre-recorded in ROM 11.
  • the CPU 5 determines to which of the five patterns the subject's pattern is closest, or with which of the pre-recorded patterns the subject's pattern has the highest degree of correlation. As a level indicating the the viscoelasticity of the subject's peripheral circulation tissue, the CPU 5 outputs on the display unit 10 the character from among A-E that most closely matches the tested pattern.
  • test results are also stored in the above-mentioned storage means.
  • peripheral circulation tissue viscoelasticity levels of subjects A and B, described above, are determined as "E” and "A”, respectively, and these results are indicated on the display unit (10). These subjects' vanishing pressures are displayed as 133 g/cm2 and 167 g/cm2, respectively. By merely viewing the test results displayed automatically after a pulse wave measurement, a person can determine his own peripheral circulation viscoelasticity level.
  • the operator By operating the various function keys provided on the keyboard, the operator (or the subject) can bring up various graphs of the subject's pulse wave data on the display unit 10. These graphs enable the operator (or the subject) to learn about the subject's physical health in specific detail.
  • Ht indicates a blood viscosity index
  • GPT live function index
  • TC a lipid level value
  • the pass region of the BPF 7 is 0.02 HZ to 20 Hz.
  • the amplifier 8 has a gain of 12 dB.
  • Pressure target values are defined in 10 levels from a minimum of 20 g/cm2 to a maximum of 200 g/cm2, with an increment of 20 g/cm2.
  • measurements were taken in a dark room at a room temperature of 23 ⁇ 1°C, after the subject was allowed to rest for 20 minutes in the sitting position after fasting. Each subject was required to control his or her breathing at a rate of 18 breathing motions per minute for the duration of an 80-second pulse wave measurement period.
  • Figure 12 shows the amplitude waveform (solid line A) of the pulse wave signals for subject C at an applied pressure of 40 g/cm2 and the associated respiration waveform (solid line B).
  • the horizontal axis indicates time (in seconds), and the vertical axis shows voltage (mV).
  • the waveform represented by solid line A indicates fluctuations that are synchronous with respiration and envelope components, originating from the autonomous nervous system function, and that change relatively slowly, as well as pulse wave signals.
  • Figure 13 shows the results of the FFT analysis of the pulse wave data indicated in Figure 12.
  • Figure 13 corresponds to Figure 3.
  • peak P2 which occurs at the frequency 0.3 Hz, similar to peak P1 in Figure 3, appears to be from fluctuations associated with the subject's breathing control (the self-regulated breathing control at a rate of 18 breathing motions per minute, as noted above).
  • Figures 14-16 show the amplitudes (solid lines C-S1, D-S1 and E-S1) of the fundamental waves, the amplitudes (solid lines C-S2, D-S2 and E-S2) of the second harmonic waves, and the amplitudes (solid lines C-S3, D-S3 and E-S3) of the third harmonic waves of the pulse wave spectra at various applied pressure values for subjects C, D, and E.
  • the horizontal axis shows the pressure (g/cm2) and the vertical axis the amplitude (mV).
  • the graph in Figure 14 shows maxima at two locations, when the applied pressure is 40 g/cm2 and 120-140 g/cm2, for any of the fundamental wave, second harmonic wave, or third harmonic wave amplitudes.
  • the pattern which shows this type of change is denoted as pattern M1.
  • the graph in Figure 15 shows a maximum at one location, when the applied pressure is 80-100 g/cm2, for any of the fundamental wave, second harmonic wave, or third harmonic wave amplitudes. At higher pressure values the curve decreases gradually.
  • pattern M2 The pattern which shows this type of change is denoted as pattern M2.
  • the graph in Figure 16 shows a maximum at one location, when the applied pressure is 80 g/cm2, for any of the fundamental wave, second harmonic wave, or third harmonic wave amplitudes. Beyond this pressure value the curve decreases rapidly.
  • pattern M3 The pattern which shows this type of change is denoted as pattern M3.
  • subjects who showed abnormal blood pressure and hematologocal test results as conducted by a physician produced a pulse wave spectral change pattern that matched M3.
  • Figure 17 is an enlargement of the amplitude waveform of subject E's pulse wave signals at the applied pressure 80 g/cm2.
  • the waveform for the output period T of pulses show waves indicated by codes a through c.
  • Wave a is referred to as an ejection wave, b as a tidal wave, and c as a dicrotic wave.
  • the maximum values of ejection waves and dicrotic waves are defined as peaks Vp and Vd, respectively.
  • the time in which the first ejection wave that occurs is at a level 10% to 90% of peak Vp is defined as the rise time Tr (msec), and the time in which the level is 50% of peak Pv is defined as the half width (msec) of the pulse waveform.
  • Figure 18 is a graph plotting the locus between the ratios of peak values Vp to Vd (Vd/Vp) (the horizontal axis) versus rise time Tr (the vertical axis) when the applied pressure is allowed to vary from 20 g/cm2 to 140 g/cm2.
  • the solid line a indicates the locus for subject C
  • the broken line b indicates that for subject E.
  • pattern M11 The pattern of change indicated by solid line a is denoted as pattern M11 and the pattern of change indicated by broken line b is denoted as pattern M12.
  • Subject C whose graph matches pattern M11, indicate normal blood pressure and hematological values.
  • subject E whose graph matches pattern M12, shows blood pressure and hematological test results exceeding the normal value. This subject was diagnosed by a physician as having circulation system abnormalities.
  • this embodiment permits the automatic measurement of subjects' fingertip plethysmograms relative to various applied pressure values and the objective display of the behavior of pulse waves relative to an applied pressure, based on changes in the frequency spectra of pulse waves as a function of change in applied pressure.
  • an analysis database can be created for each subject for use in his or her health management. Further, based upon these databases, the patterns used for judging the results of analyses (patterns A through E in this embodiment) can be modified, and patterns can be subdivided into finer categories in order to construct pulse wave analysis devices that incorporate further improvements in accuracy.
  • Figure 19 is a graph of applied pressure values (plotted on the horizontal axis) and the ratios of peak Vp of the aforementioned drive waves to peak Pd of the aforementioned superimposed waves (Vd/Vp), plotted on the vertical axis, covering six male subjects.
  • the results indicate the occurrence of individual differences at the pressure at which the Vd/Vp ratio reached its maximum.
  • a similar investigation of the ratio (Th/T) of pulse output period T to half-width period Th also indicates the occurrence of individual differences at the pressure at which the Th/T ratio reaches its maximum.
  • Figure 20 is a graph which shows the relationship between ages (horizontal axis) and rise times Tr (vertical axis) of the subjects when pressure is applied so that in each subject the Vd/Vp ratio reaches its maximum.
  • Figure 21 is a graph which shows the relationship between ages (horizontal axis) and rise times Tr (vertical axis) of the subjects when pressure is applied so that in each subject the Th/T ratio reaches its maximum.
  • Figure 22 is a graph which shows the relationship between the ages (horizontal axis) of subjects and their artery hardening indices (vertical axis) as obtained from blood tests.
  • the index which is the amount of "bad” cholesterol divided by the amount of "good” cholesterol, is considered to be indicative of the extent of aging of the blood vessels.
  • the pulse wave analysis device of this embodiment has a configuration similar to that of the equipment shown is Figure 1.
  • This pulse wave analysis device in its ROM (11), contains either a formula or a table indicating the correlation between rise time Tr and age, as shown by the solid lines in Figures 20 and 21.
  • the device is operated as follows:
  • This method permits diagnoses under conditions wherein the state of a subject's blood vessels can be determined most clearly, and thus enables one to make accurate diagnoses.
  • This embodiment proposes a portable pulse wave analysis device that implements the pulse wave measurement function of the pulse wave analysis device described in Embodiment 1 and the function of determining the viscoelasticity of subjects' peripheral circulation tissues by means of the spectral analysis of measurement results. Specifically, this embodiment proposes a pulse analysis device that can be built into a wrist-watch.
  • This pulse wave analysis device is to provide a means of simple daily analyses by ordinary people for their own health management.
  • the key considerations are ease of use and a compact design so that the pulse wave analysis device can easily fit into a wrist-watch.
  • Figure 8 shows the configuration of the pulse wave analysis device, built into a wrist-watch, of the second preferred embodiment of the present invention.
  • 20 denotes the wrist-watch proper, which contains an LCD display unit 21, a finger-butt 22, a time-setting button 23, and an analysis mode button 24.
  • the LCD display unit 21 consists of a time display unit 21a and a message display unit 21b. During both normal usage and the analysis mode, the time display unit 21a indicates the current time. Because the analysis mode continues to display time, the operator, if desired, can check the current time while performing an analysis.
  • the message display unit 21b shows the date and the day of the week.
  • the analysis mode it displays measurement and analysis messages and related information.
  • the finger-butt 22 is that part of the device against which the tip of the second finger of the hand which is not wearing the wrist-watch is pressed.
  • the time-setting button 23 is used to set time as in any ordinary wrist-watch.
  • the analysis mode button 24 is used to start and stop the analysis function.
  • Figure 9 shows the internal configuration of the pulse wave analysis device to be built into a wrist-watch.
  • the underside of the finger-butt 22 is provided with an optical fingertip plethysmogram sensor 25 and a stress gauge 26.
  • the optical fingertip plethysmogram sensor 25 is composed of an infrared (940 nm wavelength) light-emitting diode 35 and an optical sensor (a phototransistor) 36.
  • the light emitted from the infrared light-emitting diode 35 is reflected through the blood vessels in the finger tip placed on the finger-butt 22, and is picked up by the optical sensor 36 where it undergoes a photoelectric conversion, thus producing pulse wave detection signal M.
  • pressure signal P that is detected is proportional to the pressure exerted by the subject's finger through the finger-butt 22.
  • BPF band filter
  • ADCs analog/digital converters
  • ADC 29 converts the pulse wave signals (analog signals) supplied through the BPF 27 and the amplifier 28 into 8-bit digital signals that are quantized in 256 steps.
  • the sampling frequency f of ADC 29 is set so that it is greater than or equal to double the frequency band of the pulse wave signals.
  • ADC 33 converts pressure signal P, detected by the stress gauge 26, into digital signals and outputs them.
  • 30 denotes a controller, 31 ROM, and 32 a display circuit.
  • ROM 31 stores in its memory a control program for the measurement of pulse waves, a fast Fourier transform (FFT) program that analyzes the pulse wave spectra obtained through measurement, and programs that analyze a subject's physical health based upon the results of the spectral analyses.
  • FFT fast Fourier transform
  • A-C ising on the right, flat, and declining on the right
  • These patterns are used to analyze the condition of the subject's peripheral circulation tissue.
  • the controller 30 executes the programs stored in ROM 31 in order to determine the subject's pulse wave spectra at various pressure values and analyze the subject's pulse waves based on the spectra thus obtained. Specifically, the controller performs the FFT processing of the pulse wave signals output from the ADC 29 and computes the level HL of their fundamental waves.
  • five gradations of applied pressure are defined: 67, 83, 100, 117, and 133 g/cm2.
  • the applied pressure is not automatically controlled; rather, the amount of pressure applied depends on how firmly the subject presses his finger.
  • an appropriate, allowable range must be established for each level of applied pressure.
  • an allowable range of g/cm2 is defined for each of the above applied pressure values.
  • the controller 30 sequentially transmits to the display circuit 32 message date which show the analysis procedures and graphic date which guide the user so that the subject presses on the finger-butt 22 with requisite pressure.
  • the display circuit 32 outputs these display date on the aforementioned message display unit 21b.
  • the types of analysis patterns stored in the memory for the analysis of the subject's peripheral circulation tissue viscoelasticity can be increased.
  • the levels of the second harmonic wave, as well as those of the fundamental wave, can also be computed.
  • the power for the optical fingertip plethysmogram sensor 25 and for the strain gauge 26 should be turned on only when the analysis made is on.
  • code S denotes the switch provided for the optical fingertip plethysmogram sensor 25.
  • Switch drive circuits are provided for these switches.
  • the circuits supply power intermittently to the various sensors by turning the switches on and off.
  • Figure 10A shows a timing signal that turns the switches on and off. This signal goes into the H'' (high-level) state only during the analysis mode.
  • the timing signal goes into the H'' state which turns on the switches and supplies power to both the optical fingertip plethysmogram sensor 25 and the strain gauge 26.
  • the timing signal reverts to the L'' state which turns off the switches and shuts off the power to the sensors.
  • the length of time in which the analysis mode is operative would be very small compared to the total amount of time in which the wrist-watch is worn by the user.
  • Pressing the analysis mode button 24 enables the wrist-watch as a pulse wave analysis device. Pressing the analysis mode button 24 for a second time returns the wrist-watch to its normal operation.
  • Pressing the analysis mode button 24 in the midst of an analysis causes the analysis operation to be interrupted and resets the wrist-watch to its normal operation.
  • the message display unit 21b changes into a graph display as shown in Figure 11A.
  • triangle marks ml-m5 indicate the measurement points that correspond, from left to right, to the aforementioned applied pressure values 67, 83, 100, 117, and 133 g/cm2.
  • bar-shaped marks as indicated by code p, are displayed sequentially from the left.
  • the number of displayed marks is equal to the actual amount of applied pressure as detected by the strain gauge 26. While looking at these bar-shaped marks, the subject first presses his finger against the finger-butt 22 until mark P extends to the position of mark ml which indicates the first measurement point (the condition shown in Figure 11A).
  • the current pressure is within the allowable measurement range ( ⁇ 2 g/cm2) for the first measurement point (67 g/cm2).
  • the P marks before and after the indicated P mark blink intermittently.
  • the graph display in the message display unit 21b terminates.
  • the message display unit 21b shows a "PLEASE DO NOT MOVE" message, and pulse wave signal M is detected for a specified length of time.
  • the pulse wave data are transmitted to the controller 30 via the BPF 27, the amplifier 28, and the ADC 29.
  • the controller performs the FFT processing on these pulse wave data in order to calculate level HLI of the fundamental wave.
  • Pulse wave data are collected successively as the subject presses his finger against the finger-butt 22 successively up to the fifth measurement point according to the displayed messages. As a result, levels HL1-HL5 of the fundamental waves are calculated.
  • the controller 30 determines to which of the three patterns indicated above the variation characteristic of the detected levels HL1-HL5 is closest,i,e, with which pattern the variation characteristic has the highest degree of correlation.
  • the name of the pattern thus selected is displayed on the message display unit 21b.
  • the determination is then made as to which of the five applied pressure values causes the detection level for the fundamental wave to fall below the 5 mV level.
  • the result of this determination is displayed in terms of a measurement point number (1-5) following the pattern name.
  • test result "C5" would be displayed based upon the spectral change characteristic shown in Figure 5.
  • test result "A*" would be displayed based upon the spectral change characteristic shown in Figure 6.
  • a pulse wave analysis device is built into a wrist-watch worn daily by the subject, allows him to obtain information on his peripheral circulation tissue at any time simply by pressing his finger and based upon the frequency spectrum of the pulse waves.
  • the effectiveness of the subject's personal health management could be enhanced, for example, if he were to perform diagnostic checks periodically and consult the physician or contact a medical care facility whenever any sudden change in analytical results occurs.
  • An optional memory for storing several check results can be provided so that the subject can review them periodically.
  • the present invention is by no means limited to this configuration.
  • the finger-butt can be a spring-based movable mechanism, wherein the level of the applied pressure is detected on the basis of the extent to which the spring stretches or contracts.
  • marks ml - m5 that indicate measurement points for different pressure values, are displayed on the message display unit 21b.
  • the number of bar-shaped marks that are displayed per unit of pressure can be made inversely proportional to the target pressure value so that, whenever the target pressure changes, one mark is displayed at the same position, e.g., in the center on the message display unit 21b and also that bar-shaped marks will be displayed as successively higher values for each increase in pressure up to the indicated mark.
  • indirect health tip messages 31 for different pulse wave analysis patterns can be stored in ROM so that these messages are displayed on the message display unit 21b in conjunction with the display of analytical results.
  • this embodiment uses a wrist-watch as the housing unit for a portable pulse wave analysis device
  • the present invention is by no means limited to this configuration.
  • a similar pulse wave analysis device can be incorporated into any personal articles that are worn or used on a daily basis.
  • the use of the analytical device of the present invention is by no means limited to the analysis of fingertip plethysmograms as described above.
  • the device can also be used for the analysis of radial artery pulse waves, which can be obtained by pressing the subject's wrist, as well as other types of pulse waves.
  • acoustic, electromagnetic wave, and other means to detect pulse waves can also be employed.

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  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Ophthalmology & Optometry (AREA)
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EP94305727A 1988-06-13 1994-08-02 Appareil pour analyser des ondes pulsées Expired - Lifetime EP0638281B1 (fr)

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US08/281,937 US5462273A (en) 1988-06-13 1994-07-28 Variable weight playball

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JP19262093 1993-08-03
JP19262093 1993-08-03
JP192620/93 1993-08-03
JP289635/93 1993-11-18
JP5289635A JP2979933B2 (ja) 1993-08-03 1993-11-18 脈波解析装置
JP28963593 1993-11-18

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KR102640331B1 (ko) * 2018-10-19 2024-02-26 삼성전자주식회사 생체정보 추정 장치 및 방법과, 생체정보 추정 지원 장치
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EP0968681A4 (fr) * 1997-11-20 2000-08-16 Seiko Epson Corp Appareil de diagnostic lie aux formes d'impulsion, dispositif de controle de pression arterielle, dispositif de controle de la configuration des formes d'impulsion et dispositif de controle d'effet pharmacologique
US6293915B1 (en) 1997-11-20 2001-09-25 Seiko Epson Corporation Pulse wave examination apparatus, blood pressure monitor, pulse waveform monitor, and pharmacological action monitor
EP0968681A1 (fr) * 1997-11-20 2000-01-05 Seiko Epson Corporation Appareil de diagnostic lie aux formes d'impulsion, dispositif de controle de pression arterielle, dispositif de controle de la configuration des formes d'impulsion et dispositif de controle d'effet pharmacologique
EP1421897A1 (fr) * 2001-06-21 2004-05-26 Nihon University Dispositif d'examen de maladies d'un vaisseau sanguin et dispositif de diagnostic d'un vaisseau sanguin par derivation
EP1421897A4 (fr) * 2001-06-21 2005-07-27 Univ Nihon Dispositif d'examen de maladies d'un vaisseau sanguin et dispositif de diagnostic d'un vaisseau sanguin par derivation
US7309313B2 (en) 2001-06-21 2007-12-18 Nihon University Vascular disease examining system and bypass vascular diagnosing device
EP1848321A2 (fr) * 2004-10-05 2007-10-31 Optical Vitals, LLC Appareils et procedes pour le controle non invasif de parametres sanguins
EP1848321A4 (fr) * 2004-10-05 2011-03-02 Optical Vitals Llc Appareils et procedes pour le controle non invasif de parametres sanguins
US9380951B2 (en) 2004-10-05 2016-07-05 Covidien Lp Non-invasively monitoring blood parameters
US10478075B2 (en) 2013-10-25 2019-11-19 Qualcomm Incorporated System and method for obtaining bodily function measurements using a mobile device
US10694957B2 (en) 2013-10-25 2020-06-30 Qualcomm Incorporated System and method for obtaining bodily function measurements using a mobile device
US11918323B2 (en) 2013-10-25 2024-03-05 Qualcomm Incorporated System and method for obtaining bodily function measurements using a mobile device
US11931132B2 (en) 2013-10-25 2024-03-19 Qualcomm Incorporated System and method for obtaining bodily function measurements using a mobile device

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DE69424901D1 (de) 2000-07-20
EP0638281B1 (fr) 2000-06-14
CN1105224A (zh) 1995-07-19
JPH0795966A (ja) 1995-04-11
US5623933A (en) 1997-04-29
CN1103580C (zh) 2003-03-26
US5755229A (en) 1998-05-26
JP2979933B2 (ja) 1999-11-22
DE69424901T2 (de) 2000-10-19

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